Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | TRIVASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Endologix, LLC 3910 Brickway Blvd Santa Rosa, CA 95403 |
PMA Number | P120006 |
Supplement Number | S014 |
Date Received | 07/22/2014 |
Decision Date | 09/09/2014 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01092117
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Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE FILL POLYMER KIT. |
Post-Approval Study | Show Report Schedule and Study Progress |
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